BD Oral Syringe 305210Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 30382903052104), received between Mar 12, 2024 and May 8, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Contamination” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. 10MG (NUMBER OF UNITS INSPECTED: (B)(4); SYRINGE PRINTING DEFECT: 6; PLUNGER RUBBER STOPPER DEFECT: 3; SCRATCH: 1) 7.5MG (NUMBER OF UNITS INSPECTED: (B)(4) SYRINGE PRINTING DEFECT: 1) 5MG (NUMBER OF UNITS INSPECTED: (B)(4); SYRINGE PRINTING DEFECT: 3; PLUNGER RUBBER STOPPER DEFECT: 1; SCRATCH: 1; EXTERNAL SURFACE CONTAMINATION: 1; ADHERED FOREIGN MATTER: 1) 2.5MG (NUMBER OF UNITS INSPECTED: (B)(4); SYRINGE PRINTING DEFECT: 9; SCRATCH: 1; EXTERNAL SURFACE CONTAMINATION: 1). CUSTOMER RESPONSE RECEIVED ON 4/30/2026 7:44 PM - (B)(6). COULD YOU PLEASE PROVIDE THE CATALOGUE NUMBER OF THE DEFECTIVE PRODUCT? 60000310 COULD YOU PLEASE PROVIDE THE BATCH NUMBER OF THE DEFECTIVE PRODUCT? 5094870 COULD YOU PLEASE CONFIRM IF DEFECTS WERE NOTICED PRIOR TO USE? YES WAS THERE ANY PATIENT IMPACT OR HARM? NO ¿ WAS NOT ADMINISTERED TO ANY PATIENT AS CUSTOMER HAD INSPECTED PRODUCTS BEFORE USAGE AND FOUND THE DEFECT PRIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125590 ↗
• MalfunctionMay 4, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. SYRINGE ORAL 3ML AMBER SYRINGE PRINTING DEFECTS QUANTITY: 10 PLUNGER RUBBER STOPER DEFECTS QUANTITY: 4 SCRATCHES ON SYRINGE QUANTITY: 2 EXTERNAL SURFACE CONTAMINATION QUANTITY: 1 ADHERED FOREIGN MATTER QUANTITY: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068504 ↗
• MalfunctionMay 4, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. SYRINGE ORAL 3ML AMBER. SYRINGE PRINTING DEFECTS QUANTITY: 10. PLUNGER RUBBER STOPER DEFECTS QUANTITY: 4. SCRATCH ON SYRINGE QUANTITY: 2. EXTERNAL SURFACE. CONTAMINATION QUANTITY: 1. ADHERED FOREIGN MATTER QUANTITY: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068501 ↗
• MalfunctionMay 4, 2026Contamination; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. SYRINGE ORAL 3ML AMBER. SYRINGE PRINTING DEFECTS QUANTITY: 10. PLUNGER RUBBER STOPER DEFECTS QUANTITY: 4. SCRATCH ON SYRINGE QUANTITY: 2. EXTERNAL SURFACE. CONTAMINATION QUANTITY: 1. ADHERED FOREIGN MATTER QUANTITY: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068496 ↗
• MalfunctionMay 4, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. SYRINGE ORAL 3ML AMBER. SYRINGE PRINTING DEFECTS QUANTITY: 10. PLUNGER RUBBER STOPER DEFECTS QUANTITY: 4. SCRATCH ON SYRINGE QUANTITY: 2. EXTERNAL SURFACE. CONTAMINATION QUANTITY: 1. ADHERED FOREIGN MATTER QUANTITY: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068493 ↗
• MalfunctionFeb 26, 2026Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461041 ↗
• MalfunctionFeb 26, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. VERBATIM: REGARDING LOT 5100291 THERE WAS A SYRINGE PRINTING DEFECT. TOTAL DEFECTS OF 2. I BELIEVE MY COLLEAGUE HAS CONTACTED YOURSELVES REGARDING AND PROVIDED CLEARER INFORMATION THAT SO PLEASE SEE THAT NOW AS SEPARATE COMPLAINT. REGARDING LOT 4309220 & 5094872 THAT WE RECEIVED FROM YOURSELVES WE RECEIVED, OUR CLIENT REPORTED THEY HAVE FOUND INNER SURFACE CONTAMINATION AND PLUNGER RUBBER STOPPER DEFECT AND SYRINGE PRINTING DEFECTS. TOTAL DEFECTS WAS 10. NO HARM OR PATIENT IMPACT CONFIRMED. INITIAL DATE OF EVENT WAS 06 JAN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461039 ↗
• MalfunctionFeb 13, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE ORAL 3ML AMBER CONTAINED FOREIGN MATTER. WE HAD A COMPLAINT RAISED BY A CLIENT WHERE IT WAS DISCOVERED THERE WERE DEFECTS ON THE SYRINGES. EXAMPLES WERE SYRINGE PRINTING DEFECT, PLUNGER RUBBER STOPPER DEFECT AND INNER SURFACE CONTAMINATION. PLEASE CAN YOU INVESTIGATE INTO THIS AND PROVIDE AN INVESTIGATION REPORT. MATERIAL: ORAL SYRINGE, ITEM CODE: 60000310, BATCH NUMBER: 5094872, PO NUMBER: (B)(4). DEFECT MENTIONED IN THE COMPLAINT FORM: DURING THE VISUAL INSPECTION PRIOR TO THE SECONDARY PACKAGING PROCESS AT CKK, CMO FOR JAPAN MARKET, THE FOLLOWING APPEARANCE DEFECTIONS WERE DETECTED. 10 MG, NUMBER OF UNITS INSPECTED: 1,797, ACCEPTABLE UNITS: 1,792, DEFECTIVE UNITS: 5, SYRINGE PRINTING DEFECTS: 2, PLUNGER RUBBER STOPPER DEFECT: 1, INNER SURFACE CONTAMINATION OR FOREIGN MATTER: 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334894 ↗
• MalfunctionFeb 10, 2026Contamination

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308303 ↗
• MalfunctionJan 26, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE ORAL 3ML AMBER HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ADDITIONAL ISSUES FOR THE BUCCOLAM SYRINGES. CONSIDERING THE VOLUMES OF DEFECTS THAT WE WERE OBSERVING IN THE DOSED SYRINGES, ONE BATCH OF INCOMING PRODUCT AD052001 BUCCOLAM SYRINGE 3ML LOT 100941 HAS BEEN REVIEWED. 23,000 SYRINGES FROM BATCH AD052001, LOT 100941, WERE INSPECTED BEFORE BEING LOADED INTO THE DOSING MACHINE (DIRECTLY FROM THE SUPPLIER). THE FOLLOWING DEFECTS WERE FOUND: SYRINGES WITH MISALIGNED PRINTING: (B)(4) UNITS SYRINGES WITH STAINED PLUNGERS: (B)(4) UNITS SYRINGES WITH BROKEN OR CRACKED PLUNGERS: (B)(4) UNITS SYRINGES WITH A NOTCH IN THE PLUNGER: (B)(4) UNITS SYRINGES WITH BENT PLUNGERS: (B)(4) UNITS FIND PICTURES IN THE ATTACHED DOCUMENT. NOTE THAT OUR REFERENCE FOR THE CASE IS (B)(4). BEFORE USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184863 ↗
• MalfunctionMar 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890766 ↗